FiercePharma

FDA hits Spanish drug substance maker Bioiberica with a Form 483

The FDA is citing Spanish drug materials maker Bioiberica for a number of manufacturing issues, which are outlined in a Form 483. The facility, which is located in Palafalls, Spain, was inspected by ...
FiercePharma

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures

Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping. FDA inspectors visited ...
CNBCTV18

Aurobindo Pharma shares drop 4% after US FDA flags lapses at Unit-7

The US FDA had inspected Aurobindo's Unit-7 between January 28 and February 10, 2026. The inspection observations pointed to ...
Becker's ASC

FDA Form 483 Outlines Conditions Observed at NECC

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...
MD&M East

Responding to FDA Form 483 and Warning Letters: Dos and Don’ts

There is a scene in the old Rodney Dangerfield movie Back to School in which Dangerfield’s character, Thornton Melon, is preparing to take an oral exam from all his professors. One particularly stern ...
MarketWatch

2 Day Virtual Drug and Biotech Products FDA Regulatory Compliance Training Course: Practical Applications of the Graded Approach in Manufacturing, Testing, and Quality Control ...

The "FDA Regulatory Compliance for Drug and Biotech Products (Nov 12th - Nov 13th, 2025)" training has been added to ResearchAndMarkets.com's offering. Regulatory Compliance is the level of activity ...